SHANGHAI, June 30, 2023 /PRNewswire/ — Bioheart (02185.HK), together with its holding subsidiary Angiocare announces the clinical result for Iberis-HTN at China Interventional Therapeutics 2023. Iberis-HTN is a prospective, multicenter, blinded, randomized controlled trial to evaluate the safety and efficacy of the Iberis® Multi-Electrode Renal Artery Radiofrequency Ablation Catheter System for the treatment of primary hypertension (NCT02901704). The study was led by Academician Runlin GAO and Professor Xiongjing JIANG from Fuwai Hospital. 217 subjects were enrolled in the trial. The results showed that the RDN group achieved the primary clinical endpoint of efficacy (change in mean systolic blood pressure from baseline during 24-hour ambulatory blood pressure at 6 months after the procedures) and was significantly superior to the sham control group. The 24-hour systolic ABPM for Renal denervation (RDN) group was reduced by 11.93 mmHg compared to baseline and the sham group was reduced by 2.58 mmHg. The net change between groups is 9.35 mmHg reduction with statistical significance (P<0.0001). No device related major adverse events were observed. The safety and efficacy of Iberis® were demonstrated in the study.
Iberis®2nd is a catheter-based, procedure for the treatment of hypertension. Iberis®2nd has filed the registration application in China, received CE mark in EU in 2016 and has finished First in Human trial in Japan. Iberis® 2nd is currently the only RDN system globally with CE marking that can be used for both transradial approach (TRA) and transfemoral approach (TFA). TRA is preferred by interventionalists with fewer access site complications, shorter hospital stays and less overall procedural cost. TRA also enables RDN therapy to be conducted on an outpatient surgery basis. Iberis® 2nd can be used with 6F guiding to achieve complete ablation of renal main artery and branches resulting in better efficacy. A post-marketing trial RADIUS-HTN was initiated in 2022 in EU to compare the effectiveness of RDN performed via TRA and TFA. The principal investigator for RADIUS-HTN is Professor Felix Mahfoud, MD from Saarland University Hospital, Homburg/Saar and the chairman of the Arterial Hypertension Working Group of the German Cardiac Society.
Shanghai Bio-heart Biological Technology Co., Ltd is a leading cardiovascular innovative medical device company with global reach. Bioheart’s mission is ‘Turn innovation into quality care’. Bioheat focuses on Bioresorbable scaffolds, Renal Denervation and Drug coated balloons addressing unmet clinical needs.
SOURCE Shanghai Bio-heart Biological Technology Co., Ltd